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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K925682
Device Name BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED
Applicant
Biopro, Inc.
17 17th St.
Port Huron,  MI  48060
Applicant Contact MARC F MALOOLEY
Correspondent
Biopro, Inc.
17 17th St.
Port Huron,  MI  48060
Correspondent Contact MARC F MALOOLEY
Regulation Number888.3353
Classification Product Code
LZO  
Date Received11/06/1992
Decision Date 01/07/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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